1. Field of the Invention
This invention relates to novel compositions having therapeutic effects. The invention further relates to a novel method for treating or preventing hypercholesterolemia in animals.
2. The Prior Art
Pathological conditions which can afflict warmblooded animals can involve the absorption of cholesterol, and associated hypercholesterolemia. For example, epidemiological studies have demonstrated with few exceptions that populations consuming large quantities of saturated fat and cholesterol have a relatively high concentration of serum cholesterol and a high mortality from coronary heart disease. Conversely, the serum cholesterol levels and the mortality from coronary disease are low in populations with a low consumption of saturated fat and cholesterol. While it is recognized that other factors can also contribute to the development of this disease there appears to be a continuous relationship between the concentration of serum cholesterol, coronary disease, and coronary mortality. It is also known that cholesterol accumulates in various parts of the circulatory system, atherosclerosis, or in soft tissues, xanthomatosis.
Various agents have been suggested and/or effectively used to lower plasma and total body cholesterol levels. These include nonabsorbable anion exchange resins such as Colestipol or Questran, plant sterol, e.g., .beta.-sitosterol, linoleoyl amide and certain antibiotics. These agents act in varying degrees to block the absorption of dietary cholesterol or the enterohepatic flux of cholesterol, e.g., by binding cholesterol-rich bile salts (non-absorbable anion exchange resins). Plant sterols inhibit cholesterol takeup by the serum by decreasing its solubility in oily material which is necessary for absorption from the intestinal tract. Neomycin has been tested because of its digitonin-like cholesterol precipitating effect in the gastrointestinal tract. But the use of this antibiotic agent for controlling cholesterol levels in the body is not entirely suitable.
None of these agents is ideally acceptable for lowering cholesterol levels either because of undesirable side effects, too large amounts are required, or excessive amounts of carrier are required because of the properties of the agent.
Wright, et al., PROC. SOC. EXPL. BIOL. MED. 115, No. 2, pp. 497-502, postulate the use of mineral oil to provide means for extracting cholesterol from the intestinal tract, but note that because the solubility of cholesterol in mineral oil is low, very large amounts of mineral oil would have to be ingested in order to be effective.
U.S. Pat. No. 3,600,186 to Mattson, et al. discloses low calorie fat-containing food compositions in which, at least, a portion of the fat content is replaced with a sugar fatty acid ester, said fatty acid ester having at least four fatty acid ester groups with each fatty acid having from 8 to 22 carbon atoms.
U.S. Pat. No. 3,093,481, Eckey, et al. relates to plastic glyceride fats containing from about 0.0l% to about 5% by weight of a fatty acid ester of a carbohydrate selected from the group consisting of oligosaccharides and dextrin whereby at least half of the hydroxyl groups of the carbohydrate are esterified with saturated fatty acids having from 14 to 22 carbon atoms. Said fatty acid esters improve the overall physical characteristics of shortening.
Thus, while the prior art teaches the use in food products of certain of the polyol esters employed in the present invention for various purposes, the pharmaceutical utility of such materials is not disclosed therein.
A more suitable pharmaceutical composition for inhibiting the absorption of cholesterol would be desirable.